Accomplia / Zimulti Application Withdrawn
Sanofi-Aventis withdrew its application to sell their obesity drug ribmonbant in the US after an advisory panel of medical experts recommended the FDA not approve the drug. Evidently, there are psychiatric side effects– including suicidal thinking– associated with the drug.
This drug is already available in the EU, where doctors are not permitted to prescribe it to patients suffering depression. In addition, the European Medicines agency is reviewing recent safety data and will issue an updated opinion on the drug this month.
Because the drug has been shown to control blood sugar levels, the company my be planning to resubmit the drug as a diabetes treatment rather than a diet drug.
If approved for the US, the drug known by brand name “Acomplia” and “Zimulti” was anticipated to be have blockbuster sales exceeding $1 billion.